New Grass Allergy Treatment Approved by the FDA

April 2, 2014

The long, terrible winter that gripped the U.S. this year seems to finally be gone. With spring, however, comes a whole new set of challenges for those Americans who suffer from pollen and grass allergies. Luckily for them, the U.S. Food and Drug Administration (FDA) today approved a new treatment for those with grass allergies.

The treatment, named Oralair, has been approved by the FDA for the treatment of allergic rhinitis, commonly known as hay fever and brought on through grass pollens. The drug is approved for use by patients aged 10 to 65.

The FDA estimates that around 30 million Americans suffer from hay fever, a small subset of the more than 500 million people around the world that suffer from the allergy.

The new drug is a once-daily tablet that dissolves under the tongue. It contains freeze-dried extracts from common grasses including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal, and Timothy. It is manufactured by the European pharmaceutical company Stallergenes.

“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” said Dr. Karen Midthun, director of the Center for Biologics Evaluation and Research at the FDA. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office. Oralair can be taken at home after the first administration.”

Oralair was approved following a safety and effectiveness trial performed in the U.S. and Europe. The trial gave around 2,500 people either Oralair or a placebo. Those that received the real drug were found to have a 16% to 30% reduction in hay fever symptoms.

As with all allergy medications, Oralair comes with a list of potential side effects. The most dangerous may be the risk the drug has of sparking severe allergic reactions itself. The most common side effect reported in the study, though, was itching of the mouth, ears, and tongue.